From the first partial epigenetic reprogramming IND cleared by the FDA to the PEARL rapamycin trial with human healthspan data, 2025–2026 marks the moment longevity science started producing human evidence.
For two decades, the longevity field produced extraordinary results in mice — and then watched those results fail to translate, or simply never get tested in humans. That era is ending. In the past twelve to eighteen months, a cluster of breakthroughs have moved from preclinical models toward human trials or produced landmark mechanistic data that sets the stage for first-in-human studies. Some represent genuine human firsts. Some are compelling mouse results pointing directly at imminent human trials. All of them matter. Here is what happened, what the evidence actually shows, and what you can do about it today.
On January 28, 2026, Life Biosciences — the company co-founded by David Sinclair — announced FDA clearance of its Investigational New Drug (IND) application for ER-100, the first partial epigenetic reprogramming gene therapy to receive FDA permission to enter human trials.
ER-100 is being tested in Phase 1 for two age-related optic neuropathies: non-arteritic anterior ischemic optic neuropathy (NAION) and open-angle glaucoma. These diseases were chosen as a proof-of-concept because retinal ganglion cells are accessible, their degeneration is measurable, and they are among the earliest tissues to show age-related decline. Phase 1 dosing was initiated in Q1 2026.
The broader significance is in the platform, not the specific indication. ER-100 uses a modified version of the Yamanaka reprogramming factors to partially reset the epigenetic state of aging cells without converting them to a pluripotent state. Sinclair's 2023 Cell paper established the theoretical basis. The IND clearance means the FDA has reviewed the preclinical data package — including extensive nonhuman primate safety studies — and judged the risk acceptable for human testing. The eye is the starting point; the platform, if it demonstrates safety, is applicable far more broadly.
What you can do now: NAD+ precursors support the sirtuin enzymes that are central to Sinclair's epigenetic aging model. They do not reprogram cells, but they maintain the same biochemical pathways.